Recalls / Class II
Class IID-1447-2019
Product
Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16
- Affected lot / code info
- Lots: M714186 M714187 M714188 EXP Oct-19; M714903 M714904 M714905 M715586 M715587 EXP Nov-19; M801441 M801442 M801443 M801444 M801445 EXP Dec-19; M811152 M811153 M811154 M811155 M811156 M814298 EXP Jul-20; M814299 M814300 M814301 M814302 EXP Aug-20; M818136 M818137 M818138 M818139 M818140 EXP Nov-20
Why it was recalled
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 113,304 90-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-05-06
- FDA classified
- 2019-07-01
- Posted by FDA
- 2019-06-26
- Terminated
- 2021-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1447-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.